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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

The Efficacy and Safety of Sirolimus for Plastic Bronchitis

Clinicaltrials.gov identifier NCT03942926

Recruitment Status Recruiting

First Posted May 8, 2019

Last update posted May 10, 2019

Study Description

Brief summary:

There is no confirmed drug therapy for plastic bronchitis. The study wish to test the effectiveness and safety of sirolimus (rapamycin) in patients with lymphatic plastic bronchitis.

  • Condition or Disease:Plastic Bronchitis
  • Intervention/Treatment: Drug: Sirolimus
  • Phase: Phase 2
Detailed Description

Plastic bronchitis is a rare respiratory disorder characterized by formation of gelatinous or rigid cast of bronchial tree. Confirmed drug therapy for plastic bronchitis is lacking. Recently, part of plastic bronchitis has been found to have dysfunction of lymphatic circulation in the lung. Pulmonary lymphatic perfusion syndrome (PLPS) is regarded as a major mechanism of lymphatic plastic bronchitis. Sirolimus (rapamycin) has not been studied in plastic bronchitis, however, it has been shown effective in several lymphatic disorders, such as lymphangioleiomyomatosis, generalized lymphatic anomaly (GLA) including lymphangiomatosis, etc. We wish to test the effectiveness of sirolimus in lymphatic plastic bronchitis.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 10 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Ten lymphatic bronchitis patients are planned to be recruited for the study. Sirolimus will be administered for 6 months.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: The Efficacy and Safety of Sirolimus for Plastic Bronchitis:a Pilot Study
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: May 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Sirolimus
Patients in sirolimus group will receive sirolimus for 6 months.
Drug: Sirolimus
Patients will receive sirolimus for 6 months.
Outcome Measures
  • Primary Outcome Measures: 1. changes of pulmonary lymphatic perfusion distribution [ Time Frame: 6 months ]
    quantitatively measured with 68Ga-NEB positron emission tomography (PET) at baseline and the end of study
  • 2. changes of coughing score [ Time Frame: 6 months ]
    measured by coughing VAS score (0-10) at baseline, 3 months and the end of study
  • Secondary Outcome Measures: 1. changes of pulmonary function (FEV1, FVC) [ Time Frame: 6 months ]
    measured by spirometry at baseline, 3 months and the end of study
  • 2. changes of six minutes walking distance [ Time Frame: 6 months ]
    measured by six minutes walking test at baseline, 3 months and the end of study
  • 3. change of health-related quality of life [ Time Frame: 6 months ]
    measure by St George Respiratory Questionnaire at baseline, 3 months and the end of study
  • 4. changes of breathlessness score [ Time Frame: 6 months ]
    measured by Borg scale (0-10) at baseline, 3 months and the end of study
  • 5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]
    Common Terminology Criteria for Adverse Events (CTCAE) was used to collect adverse effects at baseline and through study completion
Eligibility Criteria
  • Ages Eligible for Study: 13 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- plastic bronchitis

- pulmonary lymphatic perfusion syndrome demonstrated on 68Ga-NEB positron emission
tomography (PET)

Exclusion Criteria:

- Pregnancy and breastfeeding

- Severe cardiovascular, hepatic and renal dysfunction

- allergy to sirolimus or 68Ga-NEB

Contacts and Locations
Contacts

Contact: Kai-Feng Xu 010-69155039 xukf@pumch.cn

Locations

China, Beijing
Peking Union Medical College Hospital
Beijing

Sponsors and Collaborators

Peking Union Medical College Hospital

North-China Pharmaceutical Company, China

Investigators

Principal Investigator: Kai-Feng Xu, MD Peking Union Medical College Hospital

More Information
  • Responsible Party: Peking Union Medical College Hospital
  • ClinicalTrials.gov Identifier: NCT03942926 History of Changes
  • Other Study ID Numbers: PB1
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: May 10, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: The protocol and clinical study report will be shared.
  • Supporting Materials: Study Protocol, Clinical Study Report (CSR)
  • Time Frame: Data will be shared between time of completion of the study and time of publication of the study.
  • Access Criteria: contact principle investigator Dr Kai-Feng Xu via xukf@pumch.cn
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Peking Union Medical College Hospital: plastic bronchitis sirolimus
  • Additional relevant MeSH terms: Bronchitis Acute Disease